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Longitudinal and Biomarker Study in PD (LABS-PD)

This article originally appeared in the Spring 2009 edition of PDF's quarterly newsletter, News & Review.

We all know that Parkinson’s disease (PD) is progressive, meaning it will worsen over time.  But do we know how it progresses?  Does it progress the same way for everyone? 

If you know others living with PD, you may notice that their symptoms are different from yours (you have tremor, they report stiffness) or perhaps proceed at very different rates.  To examine your progression, your doctor may observe your gait, symptoms and balance, most likely using the Unified Parkinson’s Disease Rating Scale, or UPDRS.

Other than these observations, your doctor cannot objectively measure — through a blood test, MRI imaging, or another mechanism — changes in your Parkinson’s disease, nor can he or she definitively establish a Parkinson’s diagnosis. 

These challenges prompted the creation of the Longitudinal and Biomarker Study in PD (LABS-PD), sponsored by the Parkinson Study Group (PSG) and supported by the Parkinson’s Disease Foundation (PDF).  The goals of this study are to better understand the natural course of Parkinson’s motor and nonmotor symptoms, from the earliest to the latest stages of the disease, and to provide a database for the development of biomarkers — chemical and imaging instruments that track not only the progression of PD but may also predict the risk for developing it.

Lead researcher Ira Shoulson, M.D., and his colleagues intend to achieve these goals by studying, long-term, a very large group of people with PD.  Since studies like this are logistically and financially challenging to conduct, few have been attempted. 

LABS-PD has nearly 600 participants, all of whom have previously participated in a clinical trial.  In addition to these 600, LABS-PD is designed to enroll future participants from other completed trials and studies.  This means, theoretically, the study could eventually involve thousands of people in all stages of PD — making the study’s data very valuable.

Investigators will meet annually in-person with each participant to assess and record progression of motor and nonmotor symptoms and any changes in behavior and cognition.  Every six months, the team will conduct phone and mail surveys regarding diagnosis, medications, dyskinesias or dystonia, hallucinations, fatigue, sleep, utilization of health care services, social supports available and the economic impact of Parkinsonism.

In addition, researchers will collect new biological samples — blood tests, imaging (radiological) scans and DNA samples — and study past biological samples available because of prior clinical trial participation.  

Scientists hope that data from hundreds — possibly thousands — of people over many years will yield insight into progression of PD’s symptoms, rate of progression and connection between symptoms.   More importantly, researchers will compare these findings to the biological samples they collect, tracking over time how any change in the body (as shown by the samples) relates to changes in a person’s symptoms.   

By doing so, they hope to identify biomarkers, which could lead to better individualized treatment of people living with Parkinson’s.  For instance, if your doctor better understands the progression of your PD (versus someone who experiences it differently), (s)he would be better prepared to prescribe the treatment that is tailored to treat your disease.  The improved data could also serve a crucial role in improving the clinical trials through which new treatments are tested.  In turn, this may lead to newer and better therapies.

Best of all, data from LABS-PD will be shared.  Researchers, physicians, and industry partners can learn from the knowledge gained by this long term study.  As the PD community continues in our search for a neuroprotective therapy — one that not only treats Parkinson’s symptoms, but actually slows or stops the disease  — this valuable data and collaboration will help us get there.

In fiscal year 2009, PDF is supporting the LABS-PD study with a grant of $100,000.  Following a pilot period of two to three years, the study sponsors expect to present a proposal for a larger and longer-term grant from the National Institutes of Health.